NCT03254355

Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion

Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led to the discovery of this previously unknown major injury and further research now enables its diagnosis with readily available techniques. Avulsion injury has alarming consequences because it has been associated with a higher rate of urinary incontinence in the postpartum period as well as the long-term development of other major urogynecological conditions such as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from severe symptoms with significant related impacts on physical activities, overall well-being and quality of life, but they also present a higher rate of surgical failures. Moreover, it is still unknown whether the most recommended first-line treatment for urinary incontinence -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot study conducted by our team supports the rationale and the efficacy of physiotherapy for improving PFM function in women with avulsion, despite their major muscle injury. Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in women with avulsion at 9-months after randomization compared to a waiting-list control group. Secondary objectives: 1. To compare physiotherapy to the control group after treatment and at 9-months after randomization in terms of: a) incontinence and prolapse (objective quantification, symptoms and related impact); b) PFM morphology and function; c) sexual function; d) self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change. 2. To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral) on the response to physiotherapy treatment on the aforementioned outcomes.

Detailed description

This is a multicenter randomized controlled trial using a parallel group design that involves women with a confirmed diagnosis of avulsion and suffering from urinary incontinence. Participants will be randomized into either physiotherapy or a waiting-list control group. Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9 months after randomization. Women in the control group will receive full-body relaxation massage which has shown no effect on continence but was selected to control for effects of attention received by the therapist. After the 9-month assessment, women assigned to the control group will receive the same physiotherapy treatment and undergo a last assessment.

Conditions

• Urinary Incontinence
• Postpartum
• Pelvic Floor; Perineal Rupture, Obstetric
• Physiotherapy

Interventions

Type	Name	Description
PROCEDURE	Multimodal physiotherapy	12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback

Timeline

• Start date: 2017-08-28
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2017-08-18
• Last updated: 2023-06-15

Locations

1 site across 1 country: Canada